Functional Genomics Program. The Functional Genomics Program will commence promptly following the adoption of the Development Plan for the Functional Genomics Program, or if later, the date specified in the Development Plan for the commencement of the Functional Genomics Program. Any databases and data mining technologies [***] shall be included solely as specified in the Functional Genomics Program Development Plan, and in each case subject to any applicable Third Party agreements. • The Parties will mutually agree upon the timing for drafting and negotiating a Development Plan (including the budget therefor) for the Functional Genomics Program (the “Functional Genomics Development Plan”), which Development Plan shall specify the date on which the Functional Genomics Program shall commence. • GSK will be primarily responsible for and shall be the Lead Party for Development and Manufacturing activities for the Functional Genomics Program, under the oversight of the JSC and any other governance committees as further described in Section 8 below. • The Parties will share equally all Development Costs associated with activities under the Functional Genomics Development Plan, in accordance with the budget therefor, with each of GSK and Vir bearing 50% of such Development Costs. Any Development Costs incurred in excess of the agreed upon budget (including any pre-agreed overage percentage) in the Genomics Development Plan would be subject to the terms set forth in Section 5 below. • The Definitive Collaboration Agreement will set forth the operational terms for reconciliation of Development Costs as between the Parties in accordance with the above cost-sharing ratios, which reconciliation shall be [***] except as otherwise agreed by the Parties.
Appears in 1 contract
Sources: Preliminary Collaboration Agreement
Functional Genomics Program. The Functional Genomics Program will commence promptly following the adoption of the Development Plan for the Functional Genomics Program, or if later, the date specified in the Development Plan for the commencement of the Functional Genomics Program. Any databases and data mining technologies [***] shall be included solely as specified in the Functional Genomics Program Development Plan, and in each case subject to any applicable Third Party agreements. • The Parties will mutually agree upon the timing for drafting and negotiating a Development Plan (including the budget therefor) for the Functional Genomics Program (the “Functional Genomics Development Plan”), which Development Plan shall specify the date on which the Functional Genomics Program shall commence. • GSK will be primarily responsible for and shall be the Lead Party for Development and Manufacturing activities for the Functional Genomics Program, under the oversight of the JSC and any other governance committees as further described in Section 8 below. • The Parties will share equally all Development Costs associated with activities under the Functional Genomics Development Plan, in accordance with the budget therefor, with each of GSK and Vir bearing 50% of such Development Costs. Any Development Costs incurred in excess of the agreed upon budget (including any pre-agreed overage percentage) in the Genomics Development Plan would be subject to the terms set forth in Section 5 below. • The Definitive Collaboration Agreement will set forth the operational terms for reconciliation of Development Costs as between the Parties in accordance with the above cost-sharing ratios, which reconciliation shall be [***] except as otherwise agreed by the Parties. Diligence Each Party will use commercially reasonable efforts to conduct the activities assigned to it under each Development Plan and to enable GSK to seek and obtain regulatory approval for any Collaboration Product progressed thereunder in the United States, the European Union, and the United Kingdom. The Parties further agree that, with respect to a Collaboration Product, the Parties will discuss and agree on [***]. Regulatory Matters In general, the Lead Party for a given Collaboration Program shall have the right to prepare and file for, in its own name, and will own all regulatory applications and approvals for any Collaboration Product under such Collaboration Program. The Parties will discuss and seek to agree upon the appropriate regulatory strategy for each Collaboration Product, taking into account any accelerated pathways to regulatory approval that may be available in connection with CoVID-19 and other diseases associated with coronavirus infection, provided that the Lead Party will have the right to make a final decision in connection with regulatory activities and strategy for Collaboration Products for which it is the Lead Party. Notwithstanding the foregoing, with respect to any Collaboration Product for which Vir is the Lead Party, unless GSK has exercised its Opt-Out Right, any NDA or BLA for such Collaboration Product shall be filed in the name of GSK, and [***].
Appears in 1 contract
Sources: Preliminary Collaboration Agreement (Vir Biotechnology, Inc.)